Pharmacovigilance
Pharmacovigilance is the science of monitoring, assessing, and preventing adverse drug reactions (ADRs) and other drug-related problems. It involves the collection of data from clinical trials, healthcare professionals, and patients. The goal is to ensure the ongoing safety and effectiveness of medications after they are marketed.
Signal Detection, Evaluation and Management
Signal detection in pharmacovigilance involves identifying potential safety concerns or patterns of adverse events related to a drug. Evaluation assesses the strength and validity of these signals through data analysis and expert review. Management involves taking actions to mitigate risks, such as labeling updates, warnings, or additional studies
Drug Safety Reports (PSUR , SUSAR)
Drug Safety Reports include PSURs (Periodic Safety Update Reports) and SUSARs (Suspected Unexpected Serious Adverse Reactions). PSURs provide a comprehensive review of a drug’s safety profile, summarizing new safety data and trends over time. SUSARs are reports of serious, unexpected adverse events that occur during clinical trials